dcsimg
For Healthcare ProfessionalsIntended for US Audiences

Efficacy

In a multicenter, open-label, prospective, randomized, 2-arm, controlled post marketing clinical study of the relative efficacy of ADVATE [Antihemophilic Factor (Recombinant)] use in 2 prophylactic treatment regimens compared to that of on-demand treatment, 53 previously treated patients (PTPs) with severe to moderately severe hemophilia A (FVIII level ≤2 IU/dL) were analyzed in the per-protocol group. Subjects were initially treated for 6 months of on-demand therapy and then randomized to 12 months of either an every-second-day (standard) prophylaxis regimen (20-40 IU/kg every 48 hours) or an every-third-day (pharmacokinetic-driven) prophylaxis regimen (20-80 IU/kg every 72 hours).1

Striving toward a goal of zero bleeds: Prophylaxis with ADVATE

-0%1%2%3%4%5%6%7%8%9%10%11%12%13%14%15%16%17%18%19%20%21%22%23%24%25%26%27%28%29%30%31%32%33%34%35%36%37%38%39%40%41%42%43%44%45%46%47%48%49%50%51%52%53%54%55%56%57%58%59%60%61%62%63%64%65%66%67%68%69%70%71%72%73%74%75%76%77%78%79%80%81%82%83%84%85%86%87%88%89%90%91%92%93%94%95%96%97%98%99%100%
of patients

experienced zero bleeds
during 1 year on prophylaxis1

(n=22 in the per-protocol group of 53)

ADVATE prophylaxis may help your patients prevent or reduce the frequency of bleeds1

Significant reduction in median ABR with prophylactic treatment compared with on-demand treatment1

  • 97% reduction in median annual joint bleed rate from 38.7 to 1 after switching from on-demand to prophylaxis1
  • 0 subjects developed factor VIII inhibitors or withdrew due to an adverse event (AE)4
  • One case of a possible low-titer FVIII inhibitor (0.4 BU mL-1). It was unconfirmed and unaccompanied by symptoms of inhibitors, and it disappeared at the subject’s subsequent test.4
Reduction in bleeds when switched from on-demand to prophylaxis with ADVATE [Antihemophilic Factor (Recombinant)]: 44 bleeds (IQR, 20.8) reduced to 1 bleed (IQR, 4.1), resulting in a 98% reduction in bleeds.
Low median ABR across bleeding types while on prophylaxis (N=53) with ADVATE [Antihemophilic Factor (Recombinant)]: 0 to 1 ABR depending on type of bleed.

After 12 months of prophylactic treatment with ADVATE, improvements in physical health-related quality of life and overall Physical Component Score were seen based on changes in:*1,3

  • Bodily Pain: Statistically significant improvements in the amount of pain experienced by a patient and how much pain interferes with normal work
  • Role Physical: Clinically meaningful improvements in physical health-related quality of life

* Clinically meaningful changes were not seen in the physical health-related sub-categories of General Health and Physical Functioning and the mental health-related component score and sub-categories of Mental Health, Role Emotional, Social Functioning, and Vitality.

Physical Component Score Findings: Bodily Pain: reduced levels of pain and improvements in the limitations of work due to pain Physical Functioning: changes not observed in limitations to a range of minor and major physical activities General Health: changes not observed in the views and expectations of overall health Role Physical: clinically meaningful improvements in the ability to perform work or other daily activities
Physical Component Score Findings: Bodily Pain: reduced levels of pain and improvements in the limitations of work due to pain Physical Functioning: changes not observed in limitations to a range of minor and major physical activities General Health: changes not observed in the views and expectations of overall health Role Physical: clinically meaningful improvements in the ability to perform work or other daily activities